The Food and Drug Administration (FDA) has issued a warning regarding reports of deaths that occurred in patients with liquid-filled intragastric balloon systems used to treat obesity since 2016.
Four patients had the Orbera Intragastric Balloon System (by Apollo Endosurgery) placement and one patient had the ReShape Integrated Dual Balloon System (by ReShape Medical, Inc.) placement. Deaths in all five patients occurred within one month of balloon placement with three occurring as early as 1–3 days after placement.
The FDA has also received two additional reports of death within the same time period that may possibly be related to balloon placement: one gastric perforation associated with Orbera Intragastric Balloon System and one esophageal perforation associated with ReShape Integrated Dual Balloon System.
The FDA has not determined the root cause or incidence rate of patient death. Neither the devices nor the insertion procedures (eg, gastric and esophageal perforation, intestinal obstruction) have been directly attributed to the patient deaths. In February 2017, clinicians were asked to closely monitor patients with liquid-filled intragastric balloon systems used to treat obesity for risks of acute pancreatitis and spontaneous over-inflation. The labeling for the devices was updated to reflect these potential risks since the FDA letter issuance. The Agency is working with the manufacturers to determine the cause of the unanticipated deaths and to monitor these possible complications.
The FDA will also collect more data from the ongoing, required post-approval studies for these devices and will inform the public as new information becomes available.
For more information visit FDA.gov.